Question 1

The audit report should be issued within ____________ .

Options :

A : 60 days from audit closing date

B : An agreed period of time

C : 30 months from audit closing date

D : 30 days from audit closing date

Answer: B

Question 2

According to 21 CFR 830, generally the UDI rule requires a UDI of a device on ______________.

Options :

A : Device label and package

B : Device package

C : Device itself as a permanent UDI

D : Device label

Answer: A

Question 3

Which of the following is not a terminal sterilization process?

Options :

A : Moist heat sterilization processing

B : Ethylene Oxide sterilization processing

C : Aseptic processing

Answer: C

Question 4

“Allowing insufficient time, equipment and/or training for developing the audit programme or conducting an audit” is a risk associated with ____________.

Options :

A : Resources

B : Communication

C : Planning

D : Control of documented information

Answer: A

Question 5

According to ISO 14644-1:2015, the condition where the cleanroom or clean zone is complete with all services connected and functioning but with no equipment, furniture, materials, or personnel present is referred to as ______________.

Options :

A : Non-unidirectional airflow

B : As-built condition

C : Operational condition

D : Unidirectional airflow

Answer: B